J&J to meet Justice on Natrecor claims

Johnson & Johnson lawyers are prepping for a meeting next week at the Justice Department to talk about Natrecor. According to The Recorder, J&J is making a last-ditch effort to persuade prosecutors not to indict the company for off-label marketing of the heart failure drug at its Scios subsidiary.

Quoting lawyers familiar with the investigation, The Recorder reports a criminal charge against J&J is "under serious consideration," and a handful of former executives are also under scrutiny. The government's accusation: Scios methodically pitched Natrecor for chronic heart problems besides heart failure.

Whether company reps pushed the idea or not, it's clear that doctors gave patients lots of off-label infusions of the IV drug, helping to push sales to $111.2 million in 2002--more than double the $47.3 million the previous year. By 2005, safety worries arose, leading Medicare to restrict reimbursement for the drug; the government program would only pay when Natrecor was used in hospitals.

Like so many recent off-label allegations, the Scios case began with a whistleblower. In 2005, a qui tam suit accused Scios of an "extensive and far reaching" off-label marketing campaign for Natrecor. Sales reps were told to talk up the off-label uses to doctors, the suit alleges, and the company sponsored seminars about the benefits of using Natrecor off-label. Will this whistleblower case end in a big settlement deal? We'll have to wait and see.

- read The Recorder piece
- check out the Pharmalot post

ALSO: Uber-prosecutor Michael Loucks is leaving the Boston U.S. Attorney's office, where he went after some of the biggest of Big Pharma, including Pfizer and GlaxoSmithKline. Report